A Major Step Forward in HIV Prevention
- The INSTI® HIV Self Test delivers highly accurate results in 60 seconds or less, the fastest home-use HIV rapid test available.
- FDA-approved and ready for U.S. consumers, providing a private and reliable way to learn their HIV status.
- A portable and discreet self-testing option that helps overcome barriers to traditional healthcare.
- Expanding testing access is critical to reducing HIV infections by 90% by 2030 as part of the U.S. public health goal of Ending the HIV Epidemic (EHE).
FDA Approves bioLytical’s INSTI® HIV Self Test
RICHMOND, British Columbia, Oct. 14, 2025 (GLOBE NEWSWIRE) — HIV testing just became faster, easier, and more accessible. The U.S. Food and Drug Administration (FDA) has approved the INSTI® HIV Self Test from bioLytical Laboratories Inc. (bioLytical), making it the first one-minute HIV self-test available in the U.S.
“HIV testing should be simple, fast, and accessible for everyone,” said Robert Mackie, CEO of bioLytical. “By offering accurate results in just 60 seconds, we are empowering people to take control of their health, without waiting for clinic appointments or lab results.”
With its discreet and portable design, the INSTI® HIV Self Test allows people to test for HIV anywhere, anytime, privately and on their own terms.
Why Rapid HIV Testing Matters
HIV remains a serious public health challenge in the U.S.:
- An estimated 1.2 million Americans are living with HIV.
- Approximately, 13% of people living with HIV don’t know they have it.
- Most new HIV infections come from individuals who are unaware of their status.
- Over 30,000 new infections occur each year in the U.S.
- Early detection improves treatment outcomes and significantly reduces transmission risk.
By making HIV self-testing faster, easier, and more accessible, the INSTI® HIV Self Test helps address critical gaps in screening, especially for those who face barriers to traditional healthcare due to stigma, cost, or location.
“The FDA approval of the INSTI® HIV Self Test reflects both the scientific integrity of our work and our commitment to expanding access to rapid, reliable diagnostics,” said Ana Subramanian, Vice President of Scientific Affairs at bioLytical. “This milestone ensures that more people across the U.S. can confidently access accurate HIV testing when and where they need it most.”
Fast, Reliable, and Easy to Use
The INSTI® HIV Self Test requires just a single drop of blood from a fingertip and provides highly accurate results in just one minute, offering immediate answers and reducing the anxiety of waiting for test results.
Key Benefits:
- Ultra-fast: Results in 60 seconds or less, the fastest HIV self-test available.
- Highly accurate: Trusted reliability.
- Convenient: Shelf-stable, portable, and ideal for on-the-go testing.
- Private & discreet: Test at home, at any time, no appointments needed.
Where to Get It
The INSTI® HIV Self Test will be available soon at major retailers and online. Visit bioLytical’s website for updates and purchasing details.
A New Era of HIV Testing Accessibility
“By breaking down barriers to testing, we are helping more people take control of their health,” said Mackie. “This test is a powerful tool in the fight against HIV, providing immediate answers when they matter most.”
Self-testing supports national public health goals by reducing undiagnosed HIV cases, expanding screening opportunities, and helping connect people to care sooner.
bioLytical’s Commitment to Public Health
bioLytical will manufacture the INSTI® HIV Self Test in its state-of-the-art facility, ensuring the highest quality standards through its MDSAP: ISO 13485:2016 Quality Management System. As a global leader in rapid infectious disease diagnostics, bioLytical is committed to expanding access to fast, accurate, and reliable testing solutions.
For more information, visit bioLytical’s website.
About bioLytical Laboratories Inc.
bioLytical Laboratories Inc. is a privately owned Canadian company focused on researching, developing, and commercializing rapid medical diagnostics using its proprietary INSTI® technology platform and iStatis lateral flow line. By delivering accurate results in real-time, INSTI® and iStatis generate meaningful outcomes for medical professionals, patients, and public health organizations worldwide, making bioLytical a key partner in tackling some of the world’s most pressing healthcare challenges.
Learn more at www.biolytical.com, www.insti.com, and www.istatis.com.
Sources:
Photos accompanying this announcement are available at
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A video accompanying this announcement is available at
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